The application of optical fiber, catheter or wire-based devices, which are decorated with biologically active molecules, for diagnostic tasks such as the detection and capturing of DNA, proteins, cells, and others from biological samples or even from living organisms is known in the state of art.
Detection of biomolecules by using fibers is often related to optical detection methods that sense in-situ the attachment of DNA, proteins, cells and others to functionalised and optically transparent surfaces. Fluorescence-based detection, optical absorption, as well as surface plasmon resonances are used. A widely used functionalisation approach in these studies is the attachment of antibodies to the fiber surface by for example silane chemistries. In some cases, the fiber surface is engineered in order to introduce a tapered region, which provides higher sensitivity. The microscale structure of most of the devices consists of a flat surface. Biosensing based on fibers can be used in-vitro and in-vivo and reaches single cell resolution levels.
The catheter-based collection of biological tissue samples from living organisms for the subsequent, ex-situ analysis is a well-known method on the field of biopsy. Catheters are modified with polymeric surfaces or molecular monolayers in order to reduce complications such as venous thrombosis and infections.
WO 2006/131400 teaches the decoration of a stainless steel wire with metallic islands that are modified with antibodies for specific cell capture. The metallic islands with sizes in the 100 nm regime were fabricated by using a sphere-monolayer as a shadow mask during the deposition step of a gold layer. The gold islands were modified with thiolated linker molecules that bind specific antibodies.
Errors that generate too many or too few chromosomes can also lead to disease phenotypes. For example, a missing copy of chromosome X results in Turner's Syndrome, while an additional copy of chromosome 18 or 13 results in Edward's Syndrome or Patau Syndrome, respectively.
One of the most common chromosome abnormalities is known as Down syndrome. The estimated incidence of Down syndrome is between 1 in 1,000 to 1 in 1,100 live births. The vast majority of children with Down syndrome have an extra chromosome 21. Chromosomal abnormalities are congenital, and therefore, prenatal diagnosis can be used to determine the health and condition of an unborn fetus. Specifically, prenatal diagnosis is helpful for managing the remaining term of the pregnancy, planning for possible complications with the birth process, preparing for problems that can occur in the newborn infant, and finding conditions that may affect future pregnancies.
There are a variety of non-invasive and invasive techniques available for prenatal diagnosis including ultrasonography, amniocentesis, chorionic villus sampling (CVS), and the characterization of fetal blood cells from maternal blood, and the determination of maternal serum alpha-fetoprotein, maternal serum beta-HCG, and maternal serum estriol. However, the techniques that are non-invasive are less specific, and the techniques with high specificity and high sensitivity are highly invasive. A common invasive method is amniocentesis (also referred to as amniotic fluid test or AFT), a medical procedure used in prenatal diagnosis of chromosomal abnormalities and fetal infections. A small amount of amniotic fluid, which contains fetal tissues, is extracted from the amnion or amniotic sac surrounding a developing fetus, and the fetal DNA is examined for genetic abnormalities. This procedure is often used to diagnose the Down syndrome. Although the procedure is routine, complications include preterm labor and delivery, respiratory distress, postural deformities, fetal trauma and alloimmunisation, infection of the amniotic sac from the needle, and failure of the puncture to heal properly, which can result in leakage or infection. Serious complications can result in miscarriage. The risk of amniocentesis-related miscarriage is generally thought to be 1 in 200.
Therefore, there is a need in alternative prenatal diagnostic methods which do not include the risks known in the state of art.
The object of the invention was to provide a fiber-based device that not only detects rare bioanalytes inside living organisms or in in-vitro samples, but which detects and catches such analytes in a highly efficient way and preserves or protects them until they can be ex-situ analysed in detail. Also the production costs are supposed to be lower than in the state of art.